Dose reduction of biological treatment in patients with axial spondyloarthritis in clinical remission: Are there any differences between patients who relapsed and to those who remained in low disease activity?

Almirall, Míriam; Salman-Monte, Tarek Carlos; Lisbona, M.; Maymó, Joan

doi:10.1007/s00296-015-3288-z

Cited by 19 publications

(9 citation statements)

References 14 publications

(26 reference statements)

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“…After 2 years, 53% patients remained on a reduced dose regimen (mean: 62 ± 11% of the standard dose) [217] (2B). Consistent with these findings, other studies reported success rates in anti-TNFα dose reduction (ranging from 50 to 75% of the standard dose) in patients with axial SpA who were in remission or LDA, ranging from 55 to 96% after one year of follow-up [218][219][220][221] and from 56 to 84% after 3 years [220,222,223].…”

Section: Dose Reduction In Biological Therapysupporting

confidence: 60%

“…Better results were observed among patients undergoing the same therapy and patients in remission for longer periods [219,221] (2C). The drug survival remained unchanged during the four years (HR = 0.472, 95% CI 0.155-1.435) among 100 patients with AS for whom the dose of etanercept was reduced from 50 mg/week to 25 mg/week (or 50 mg/2 weeks) and among 34 controls who maintained the standard dose, thus supporting the efficacy of the reduced dose in patients in remission/LDA during the longest followup period [224] (2B).…”

Section: Dose Reduction In Biological Therapymentioning

confidence: 99%

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The Brazilian Society of Rheumatology guidelines for axial spondyloarthritis – 2019

et al. 2020

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Spondyloarthritis is a group of chronic inflammatory systemic diseases characterized by axial and/or peripheral joints inflammation, as well as extra-articular manifestations. The classification axial spondyloarthritis is adopted when the spine and/or the sacroiliac joints are predominantly involved. This version of recommendations replaces the previous guidelines published in May 2013. A systematic literature review was performed, and two hundred thirty-seven studies were selected and used to formulate 29 recommendations answering 15 clinical questions, which were divided into four sections: diagnosis, non-pharmacological therapy, conventional drug therapy and biological therapy. For each recommendation the level of evidence supporting (highest available), the strength grade according to Oxford, and the degree of expert agreement (inter-rater reliability) is informed. These guidelines bring evidence-based information on clinical management of axial SpA patients, including, diagnosis, treatment, and prognosis. The purpose of these guidelines is to bring evidencebased information on clinical management of axial SpA patients, including, diagnosis, treatment and prognosis, for rheumatologists, general physicians, allied-specialists (dermatology, ophthalmology and gastroenterology), and other allied-professionals, such as physiotherapists. This version replaces the previous guidelines published on May 26, 2013 [3] and should be updated every 4 years. Methods A systematic literature review was performed, with external review of an specialized group of the Brazilian

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Section: Dose Reduction In Biological Therapysupporting

confidence: 60%

Section: Dose Reduction In Biological Therapymentioning

confidence: 99%

The Brazilian Society of Rheumatology guidelines for axial spondyloarthritis – 2019

et al. 2020

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“…At least 13 prospective or retrospective studies have focused on the tapering or discontinuation of etanercept in AS, with follow-up duration varying from 8 weeks to 36 months and the maintenance rate of remission or LDA as 47-86.3% (Table 4). [8][9][10][11][12][13][14][15][16][17][18][19][20] According to a systemic review and a meta-analysis on etanercept tapering in AS patients, etanercept reduction was effectively comparable with nondecreasing standard dosages in most studies. 25,26 In our study, the flare-free maintenance rates with stepwise tapering of rhTNFR:Fc at week 48 were 91.0% and 83.3% in patients with clinical remission and LDA, respectively.…”

Section: Discussionmentioning

confidence: 99%

Disease activity guided stepwise tapering or discontinuation of rhTNFR:Fc, an etanercept biosimilar, in patients with ankylosing spondylitis: a prospective, randomized, open-label, multicentric study

Zhang

Zhu

et al. 2020

Therapeutic Advances in Musculoskeletal

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Background: The aim of this study was to evaluate disease-activity-guided stepwise tapering or discontinuation of rhTNFR:Fc, an etanercept biosimilar, in patients with ankylosing spondylitis (AS) in a prospective, randomized, open-label, multicentric study. Methods: Active AS patients with AS disease activity score (ASDAS) ⩾2.1 recruited from 10 hospitals were treated with rhTNFR:Fc 50 mg weekly for 12 weeks, and further randomized into different tapering or discontinuation groups according to ASDAS at week 12. Patients who achieved clinical remission (ASDAS < 1.3) were assigned randomly to stepwise tapering group or discontinuation group. Patients who achieved low disease activity (LDA, 1.3⩽ASDAS < 2.1) were assigned randomly to stepwise tapering, delayed tapering, or discontinuation group. All patients were evaluated every 12 weeks until week 48. The primary endpoint was cumulative flare rates in different groups at week 48. Results: A total of 311 patients were enrolled with an average ASDAS of 3.6 ± 1.0, and 259 completed 12 weeks of rhTNFR:Fc induction therapy, with 148 patients (57.1%) achieved clinical remission, 100 (38.6%) achieved LDA, and 11 (4.3%) remained as high disease activity (ASDAS⩾2.1). In patients who achieved clinical remission at week 12, stepwise tapering of rhTNFR:Fc demonstrated significantly lower flare rates at each evaluation compared with discontinuation. In patients who achieved LDA, there was no significant difference of flare rates between stepwise tapering, delayed tapering, and discontinuation. With stepwise tapering of rhTNFR:Fc, flare rates were comparable in AS patients, irrespective of initial ASDAS before tapering. Conclusion: Stepwise tapering of rhTNFR:Fc when patients achieved clinical remission was able to maintain favorable low flare rates in 48 weeks. LDA was an alternative therapeutic target, as well as an viable timing for initiation of rhTNFR:Fc tapering. rhTNFR:Fc 25 mg monthly maintained flare-free status in a considerable number of patients. However, abrupt discontinuation of rhTNFR:Fc even if patients achieved clinical remission should be avoided. Trial registration: ClinicalTrials.gov: NCT03880968, URL: https://clinicaltrials.gov/ct2/show/NCT03880968

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“…A recent study of 42 axSpA patients who underwent dose reduction of TNFi for 1 year found that 76.2% remained in remission or low disease activity at the end of the study, with shorter duration of remission before dose reduction, shorter duration of treatment with biologics, and shorter disease duration found to be risk factors for relapse . Tapering or dose reduction of etanercept has been conducted successfully in AS patients with >6 months of stable disease, with acceptable efficacy in cases that needed to restart a full dose of treatment; however, in stable patients who completely discontinued etanercept or adalimumab, a greater percentage experienced disease flares as compared to controls.…”

Section: Recommendationsmentioning

confidence: 99%

Taiwan Rheumatology Association consensus recommendations for the management of axial spondyloarthritis

et al. 2019

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Aim:To establish guidelines for the clinical management of axial spondyloarthritis that take into account local issues and clinical practice concerns for Taiwan. Method:Overarching principles and recommendations were established by consensus among a panel of rheumatology and rehabilitation experts, based on analysis of the most up-to-date clinical evidence and the clinical experience of panelists. AllOverarching Principles and Recommendations were graded according to the standards developed by the Oxford Centre for Evidence Based Medicine, and further evaluated and modified using the Delphi method. Results:The guidelines specifically address issues such as local medical considerations, National Health Insurance reimbursement, and management of extra-articular manifestations.Conclusion: It is hoped that this will help to optimize clinical management outcomes for axial spondyloarthritis in Taiwan. K E Y W O R D Sankylosing spondylitis, axial spondyloarthritis, extra-articular manifestation, IL-17 inhibitor, non-radiographic axial spondyloarthritis, spinal fracture, TNF inhibitor

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Dose reduction of biological treatment in patients with axial spondyloarthritis in clinical remission: Are there any differences between patients who relapsed and to those who remained in low disease activity?

Cited by 19 publications

References 14 publications

The Brazilian Society of Rheumatology guidelines for axial spondyloarthritis – 2019

The Brazilian Society of Rheumatology guidelines for axial spondyloarthritis – 2019

Disease activity guided stepwise tapering or discontinuation of rhTNFR:Fc, an etanercept biosimilar, in patients with ankylosing spondylitis: a prospective, randomized, open-label, multicentric study

Taiwan Rheumatology Association consensus recommendations for the management of axial spondyloarthritis

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